PMID- 25604316
OWN - NLM
STAT- MEDLINE
DCOM- 20151214
LR  - 20220409
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Print)
IS  - 0770-3198 (Linking)
VI  - 34
IP  - 3
DP  - 2015 Mar
TI  - Comparison of tocilizumab as monotherapy or with add-on disease-modifying 
      antirheumatic drugs in patients with rheumatoid arthritis and inadequate 
      responses to previous treatments: an open-label study close to clinical practice.
PG  - 563-71
LID - 10.1007/s10067-014-2857-y [doi]
AB  - This was an exploratory analysis comparing the safety and efficacy of tocilizumab 
      monotherapy with those of tocilizumab in combination with disease-modifying 
      anti-rheumatic drugs (DMARDs). Data were from a single-arm, nonrandomized, 
      open-label, 24-week study in patients with rheumatoid arthritis in which patients 
      with inadequate responses to DMARDs or tumor necrosis factor-alpha inhibitors 
      received tocilizumab 8 mg/kg intravenously every 4 weeks plus methotrexate/other 
      DMARD(s) combination therapy. If they were intolerant of methotrexate/other 
      DMARD, patients received tocilizumab monotherapy. Effectiveness endpoints 
      included American College of Rheumatology (ACR) responses (ACR20/50/70/90) and 
      disease activity score using 28 joints (DAS28). Of 1,681 patients, 239 received 
      tocilizumab monotherapy, and 1,442 received combination therapy. Methotrexate was 
      the most common DMARD (79%) used in combination therapy. The frequency of adverse 
      events (AEs), serious AEs, and AEs leading to withdrawal were similar between 
      tocilizumab monotherapy (82.4, 7.9, and 5.4%, respectively) and combination 
      therapy (76.6, 7.8, and 5.1%, respectively). No differences in ACR20/50/70/90 
      responses were observed between treatment groups (66.9%/43.5%/23.8%/10.0% vs 
      66.9%/47.2%/26.8%/8.5%, respectively; p > 0.12 for all individual comparisons, 
      including ACR50 propensity score analyses). The decrease in DAS28 was also 
      similar between treatment groups (mean +/- standard deviation: -3.41 +/- 1.49 for 
      tocilizumab monotherapy vs -3.43 +/- 1.43 for combination therapy; p > 0.33 all 
      analyses, including propensity score analyses). Tocilizumab had a comparable 
      safety profile, and was similarly effective, when used as monotherapy or in 
      combination with DMARDs in a broad population of patients with rheumatoid 
      arthritis.
FAU - Bykerk, Vivian P
AU  - Bykerk VP
AD  - Inflammatory Arthritis Center, Hospital for Special Surgery, 535 East 70th 
      Street, New York, NY, 10021, USA, bykerkv@hss.edu.
FAU - Ostor, Andrew J K
AU  - Ostor AJ
FAU - Alvaro-Gracia, Jose
AU  - Alvaro-Gracia J
FAU - Pavelka, Karel
AU  - Pavelka K
FAU - Roman Ivorra, Jose Andres
AU  - Roman Ivorra JA
FAU - Graninger, Winfried
AU  - Graninger W
FAU - Bensen, William
AU  - Bensen W
FAU - Nurmohamed, Michael T
AU  - Nurmohamed MT
FAU - Krause, Andreas
AU  - Krause A
FAU - Bernasconi, Corrado
AU  - Bernasconi C
FAU - Aassi, Maher
AU  - Aassi M
FAU - Sibilia, Jean
AU  - Sibilia J
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150122
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - I031V2H011 (tocilizumab)
SB  - IM
EIN - Clin Rheumatol. 2015 Jul;34(7):1321. PMID: 25943189
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC4348534
EDAT- 2015/01/22 06:00
MHDA- 2015/12/15 06:00
PMCR- 2015/01/22
CRDT- 2015/01/22 06:00
PHST- 2014/02/13 00:00 [received]
PHST- 2014/12/22 00:00 [accepted]
PHST- 2014/12/18 00:00 [revised]
PHST- 2015/01/22 06:00 [entrez]
PHST- 2015/01/22 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
PHST- 2015/01/22 00:00 [pmc-release]
AID - 2857 [pii]
AID - 10.1007/s10067-014-2857-y [doi]
PST - ppublish
SO  - Clin Rheumatol. 2015 Mar;34(3):563-71. doi: 10.1007/s10067-014-2857-y. Epub 2015 
      Jan 22.